BYRON-LARSON-ARTICLES
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![developing-design-controls_450x300]( "Tips For Developing Medical Device User Needs, Intended Uses, And Design Inputs")
Tips For Developing Medical Device User Needs, Intended Uses, And Design Inputs4/20/2015The FDA’s Design Control Guidance for Medical Device Manufacturers states, “Development of a solid foundation of requirements is the single most important design control activity.” This concept is likely to be self-evident to experienced medical device practitioners. However, what exactly is meant by the term “requirements”?
Byron Larson
Byron Larson is founder and president of Toltec Ventures LLC Inc., a consulting company specializing in medical device product development. Before the formation of Toltec Ventures, he was president of Toltec International Inc., and prior to that he held several engineering and engineering management roles while at Gambro AB and COBE Laboratories Inc. Larson has received BS and MS degrees in mechanical engineering and is a registered professional engineer in the state of Colorado. He can be contacted at byron.larson@toltec.biz.